3. Compositional Aspects

General Foods
Brazil

This section provides the compositional requirements for the food category and/or food products in scope and information on permitted nutrients, ingredients, and additives.

3.1 Composition Requirements

Law N° 986/1969 [1] sets out basic standards for food in Brazil. According to this law, foodstuffs must comply, in their composition, with the specifications of the respective identity and quality standard in the case of standardized foodstuffs, or with those that have been declared at the time of the respective registration in the case of fantasy or artificial foodstuffs, or non-standardized foodstuffs; thus, compositional requirements will depend on the specific food category. 

In Brazil, some food categories have specific regulations laying down their composition requirements. In the case of non-standardized foodstuffs, they shall follow horizontal regulations such as those for labeling (general and nutrition), food additives and processing aids, contaminants, GMP, etc. For food preparations that are considered culinary recipes/preparations, there are no composition requirements established in the regulation. These preparations must only meet the GMP rules for food services established in Resolution N° 216/2004 [2]. As part of the GMP rules, it is important to guarantee that the raw materials used in the preparations follow national regulations and are duly authorized by the authority (notified/registered).

Refer to Section 3.1 of specific product Guidebooks for product-specific requirements.

3.2 Raw Material Requirements

As mentioned in Section 3.1 above, the use of ingredients/raw materials will depend on the specific food category/product (Law N° 986/1969 [1]).

In addition, raw materials, like any other packaged products, must comply with Normative Instruction 211/2023 [3] establishing the technological functions, the maximum limits, and the conditions of use for food additives and technology adjuvants authorized for use in foodstuffs.

Refer to Section 3.2 of specific product Guidebooks for product-specific requirements.

3.3 Fortification

Mandatory fortification

Mandatory fortification will depend on the specific food category/product. Refer to Section 3.3 of specific product Guidebooks for product-specific requirements.

Voluntary fortification 

It must follow those provisions foreseen in Resolution RDC N° 714/2022 [4] that provide for sanitary requirements for food enrichment and restoration. 

Definition of Enrichment: the addition of one or more essential nutrients, naturally or not contained in the food, with the aim of reinforcing its nutritional value or preventing or correcting nutritional deficiencies.

For this case, the food must have its conventional sales denomination plus one of the following expressions:

1. "Enriched with Vitamin(s)"
2. "Fortified with Vitamin(s)"
3. Vitaminized"
4. "Enriched with Mineral(s)"
5. "Fortified with Mineral(s)"
6. "Enriched with Vitamin(s) and Mineral(s)"
7. "Fortified with Vitamin(s) and Mineral(s)"
8. "Enriched with ... (mention name of nutrients)"
9. "Fortified with... (cite the name of nutrients)"

The above is not applicable to food preparations.

3.4 Other Permitted Ingredients

Generally, ingredients are described with specific rules established in the specific regulation for individual food (not applicable to food preparations). There is no list of other permitted ingredients for General Foods as defined in the regulation. Refer to Section 3.4 of specific product Guidebooks for product-specific requirements.

The use of ingredients not traditionally used as food or obtained by processes not traditionally employed in the production of food may be authorized as novel foods/ingredients, in accordance with the procedures laid down in Resolution RES N° 17/1999 [5] Technical Regulation on risk assessment and food safety, and in Resolution RES N°16 /1999 [6] on the registration of novel foods and novel ingredients. 

DOCUMENTATION

For the purposes of registration, the interested party must present, in addition to the documents required according to specific legislation, the following documentation:

1. Scientific Technical Report containing the following information:
   1. product name
   2. purpose of use
   3. consumption recommendation indicated by the manufacturer
   4. scientific description of the product's ingredients, according to species of botanical, animal, or mineral origin, when applicable
   5. chemical composition with molecular characterization, when applicable, and/or product formulation
   6. description of the analytical methodology for evaluating the food or ingredient object of the petition
   7. scientific evidence applicable, as the case may be, to the proof of safety of use
      1. nutritional and/or physiological and/or toxicological tests in experimental animals
      2. biochemical assays
      3. epidemiological Studies
      4. clinical trials
      5. proof of traditional use, observed in the population, without harm to health
      6. comprehensive evidence from scientific literature, international health bodies, and internationally recognized legislation on the characteristics of the food or ingredient

3.5 Permitted Additives

In Brazil, the use of food additives is governed by Resolution RDC 778/2023 [7] which provides the general principles, technological functions, and conditions of use of food additives in foods and processing aids, and also Normative Instruction 211/2023 [8] that provides the list of food additives and processing aids with its limits to be used in each food category.

This is applicable only for raw materials, not to food preparations, as described in Section 3.2 above - Raw material requirements. If any food additive or processing aids used in the industrialized raw materials such as syrups/sauces etc., intended for food preparations, those substances must be used following Normative Instruction 211/2023 [3] establishing the technological functions, the maximum limits, and the conditions of use for food additives and technology adjuvants authorized for use in foodstuffs.

3.6 Permitted Flavors and Colors 

This is applicable only for raw materials, as described in Section 3.2 above - Raw material requirements. (Not applicable to food preparations.)

Flavorings

According to Article 3 of Resolution RDC N° 725/2022 [8], flavoring substances appearing in at least one of the following lists may be used: 

• Joint FAO/WHO Expert Committee on Food Additives (JECFA)
• Food and Drug Administration (FDA)
• Flavor Extract Manufacturers Association (FEMA)
• European Union

Additionally, botanical species of regional origin listed in Annex I of the said Resolution and their flavoring components may be used provided that they comply with the conditions of use set out in Article 7 of the regulation.

Colors 

Also listed in Normative Instruction 211/2023 [3]. Additionally, refer to Section 3.6 of specific product Guidebooks for product-specific flavors and color requirements.

3.7 Permitted Processing Aids 

Please refer to Section 3.5 above.

3.8 Additional Notes 

Trans fats

Foodstuffs must comply with the maximum amount of trans fats established by Resolution RDC N° 632/2022 [9]. According to this resolution as of January 1, 2023, the production, importation, use, and offer of partially hydrogenated oils and fats for use in food and food formulated with these ingredients are prohibited. The amount of industrial trans fats cannot exceed 2 grams per 100 grams of total fat in foods intended for the final consumer.

3.9 References

1. Law N° 986/1969 - Setting out basic standards on foods

http://www.planalto.gov.br/ccivil_03/decreto-lei/Del0986.htm

2. Resolution N° 216/2004 – Providing on Technical Regulation on Good Practices for Food Services

https://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2004/res0216_15_09_2004.html

3. Normative Instruction 211/2023. Establishes the technological functions, the maximum limits and the conditions of use for food additives and technology adjuvants authorized for use in foodstuffs

http://antigo.anvisa.gov.br/documents/10181/6561857/IN_211_2023_.pdf/108ca468-25bb-4d32-9e6b-3d96e4858140#:~:text=Estabelece%20as%20fun%C3%A7%C3%B5es%20tecnol%C3%B3gicas%2C%20os,autorizados%20para%20uso%20em%20alimentos. 

4. Resolution RDC N° 714/2022 - Provides for sanitary requirements for food enrichment and restoration

http://antigo.anvisa.gov.br/legislacao#/visualizar/487320 

5. Resolution RES N° 17/1999 - Technical Regulation on risk assessment and food safety

http://antigo.anvisa.gov.br/documents/10181/2718376/RES_17_1999_COMP.pdf/0d8b0d1e-2b81-4dbe-b78c-1605e627c486 

6. Resolution RES N° 16/1999 -Technical regulation for procedures for registration of foods and or new ingredients

http://antigo.anvisa.gov.br/legislacao#/visualizar/26327

7. Resolution RDC 778/2023 that provides the general principles, technological functions, and conditions of use of food additives in foods and processing aids

http://antigo.anvisa.gov.br/documents/10181/6561857/RDC_778_2023_.pdf/a89bb838-62e4-4471-a28f-ff28e3e97241 

8. Resolution RDC N° 725/2022 - Provides for flavouring food additives

http://antigo.anvisa.gov.br/documents/10181/2718376/RDC_725_2022_.pdf/fa9a9a0a-9e30-4c2b-8386-04b5533aa934 

9. Resolution RDC N° 632/2022 - Provides for the restriction of the use of industrial trans fats in foods

http://antigo.anvisa.gov.br/documents/10181/6414038/RDC_632_2022_.pdf/d9ff597a-6151-4b90-94e4-049e379891c9